Neuropsychiatric Disease and Treatment (May 2022)
Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia
Abstract
Larry Culpepper,1 Eduard Vieta,2 Deanna L Kelly,3 Mehul D Patel,4 Balázs Szatmári,5 Arlene Hankinson,4 Willie R Earley4 1Boston University School of Medicine, Boston, MA, USA; 2Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain; 3Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA; 4AbbVie, Madison, NJ, USA; 5Gedeon Richter Plc., Budapest, HungaryCorrespondence: Larry Culpepper, Boston University School of Medicine, 90 Sylvia Lane, Westport, MA, 02790-1406, USA, Tel +1 617 414-6225, Email [email protected]: Many medications used to treat schizophrenia and bipolar I disorder are linked to hyperprolactinemia. The effects of cariprazine, a dopamine D3/D2 receptor partial agonist, on prolactin levels in patients with schizophrenia or bipolar I disorder were evaluated.Methods: Effects on prolactin were evaluated using pooled data from randomized, double-blind, placebo-controlled studies in patients with schizophrenia (4 studies; 6-week duration; cariprazine 1.5– 3 mg/d, 4.5– 6 mg/d, and 9– 12 mg/d), bipolar mania (3 studies; 3-week duration; cariprazine 3– 6 and 9– 12 mg/d), and bipolar depression (3 studies; 6- to 8-week duration; cariprazine 1.5 and 3 mg/d). Long-term effects were analyzed using open-label studies in patients with schizophrenia (2 studies; 48-week duration) and patients with bipolar mania (1 study; 16-week duration). Change in prolactin levels (ng/mL) from baseline to study endpoint was evaluated in subsets of sex and prior medication use.Results: In patients with schizophrenia (male, n = 1377; female, n = 558), median prolactin changes were − 1.2 for males and − 7.4 for females on placebo, and ranged from − 4.2 to − 3.6 for males and − 12.4 to +0.2 for females in the cariprazine-treatment groups. In patients with bipolar mania (male, n = 570; female, n = 395), median prolactin changes were − 0.2 for males and − 1.1 for females on placebo and ranged from − 2.1 to − 3.0 for males and 0 to +1.8 for females in the cariprazine-treatment groups. Median decreases were also seen in the long-term studies of schizophrenia (range, − 14.6 to − 2.0) and bipolar mania (range, − 0.8 to +1.9). In patients with bipolar depression (male, n = 485; female, n = 780), median prolactin changes were +0.3 for males and +0.7 for females on placebo and ranged from +0.4 to +0.5 for males and +3.0 to +3.1 for females in the cariprazine-treatment groups.Conclusion: Treatment with cariprazine for schizophrenia or bipolar I disorder was associated with minimal effects on prolactin levels.Keywords: dopamine, serotonin, mania, depression, prolactin
